SEATTLE, WA.- July 11, 2023 – Pluristyx, Inc. today announced an agreement with the Advanced Regenerative Manufacturing Institute | BioFabUSA to manufacture and commercialize Pluristyx’s clinical-grade reprogrammed induced Pluripotent Stem Cells (iPSCs). This collaboration will make it possible to accelerate the scalable, consistent, and cost-effective manufacturing of stem cell derived products for patient administration.
The agreement provides ARMI | BioFabUSA, its affiliates, and Members streamlined access to high-quality clinical grade- iPSCs for cell and gene therapy manufacturing. Pluristyx’s iPSCs are derived from fully consented and regulatory appropriate donors procured under Good Tissue Practices (GTP). The iPSCs are available in two cost-effective tiers: a research-grade version for evaluation prior to licensing and a full GMP (Good Manufacturing Practice) compliant version with license. ARMI | BioFabUSA Members can also incorporate multiple proprietary panCELLa™ gene edits, including the FailSafe™ safety switch, iACT® allogeneic cell cloaking technologies, and other custom genetic modifications to create a truly universal and scalable starting material for clinical development.
“We are thrilled to expand our relationship with ARMI | BioFabUSA and provide our clinical grade iPSCs to advance the development of tomorrow’s stem cell derived therapies. As long time ARMI | BioFabUSA Members, we look forward to expanding our work to fulfill the organization’s mission of bringing revolutionary products to patients in need,” stated Benjamin Fryer, PhD, Chief Executive Officer, Pluristyx
“By working with Pluristyx to deliver clinical grade iPSCs, our members will have a reliable and stable source material, and this will help accelerate the path to commercialization. Alongside Pluristyx, ARMI | BioFabUSA is proud to deliver this opportunity and accelerate the impact of our ecosystem,” shared Deputy Director, Maureen Toohey.
Pluristyx, through its merger with Toronto-based panCELLa, offers a portfolio of unique iPSC-based technologies, proprietary genetic engineering, and related services to provide end-to-end client support throughout their product lifecycle. Pluristyx is fast becoming the leading provider of gene-edited iPSC and cell therapy solutions, accelerating the path to clinic, and providing the best route to commercialization. For more information on Pluristyx, please visit www.pluristyx.com
The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is a member-based, nonprofit organization whose mission is to advance the bioeconomy of the United States. Funded by industry and the federal government, including U.S. Department of Defense, the Institute is building the field of biomanufacturing, and providing education, and workforce development to transform healthcare.
To learn more, visit: www.armiusa.org